BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/4 X 3/8 CONNECTOR

    MDR report key: 12714555 · Received October 28, 2021

    Report

    Report Number
    1718850-2021-00049
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 30, 2021
    Report Date
    December 22, 2021
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DTL
    UDI-DI
    00803622129315
    PMA / PMN Number
    EXPEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT THAT A 3/8 X ¼ REDUCER WAS COMPLETELY OCCLUDED. THE ISSUE WAS IDENTIFIED PRIOR TO ANY PATIENT INVOLVEMENT. THE DHR REVIEW CONFIRMED THE LOT OF THE REDUCES WAS RELEASED CONFORMING TO PRODUCT SPECIFICATIONS. ANALYSIS OF THE LIVANOVA COMPLAINT DATABASE OF THE LAST 12 MONTHS IDENTIFIED TWO PREVIOUS SIMILAR EVENTS RELATED TO THE SAME CATALOGUE ITEM CODE. INVESTIGATION RESULTS SUGGESTED THE REDUCED WAS OCCLUDED BY A PLASTIC FILM LIKELY DUE TO A MOLDING DEFECT. THUS, SUGGESTING A MANUFACTURING ISSUE. THE REDUCER IS MANUFACTURED BY A LIVANOVA SUPPLIER THAT HAS BEEN FORMALLY NOTIFIED OF THE ISSUE. DUE TO OTHER MANUFACTURING NEEDS, THE CATALOGUE ITEM CODE OF THE COMPLAINED 3/8 X ¼ REDUCER WAS ALREADY PLANNED TO BE SUBSTITUTED BY ANOTHER SIMILAR REDUCER. TO PREVENT RE-OCCURRENCE, LIVANOVA ANTICIPATE THE CHANGE AND WILL DISCARD ALL THE INVENTORY OF THE COMPLAINED REDUCER. AT THE MOMENT, NO OTHER ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE WAS NO PATIENT INVOLVEMENT. LIVANOVA USA INC MANUFACTURES THE CONNECTOR. THE INCIDENT OCCURRED IN (B)(6) UNITED STATES OF AMERICA. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 1

    LIVANOVA USA INC RECEIVED A REPORT THAT A 1/4 X 3/8 CONNECTOR USED TO ATTACH TUBING IN THE CIRCUIT WAS COMPLETELY OCCLUDED. THE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612186 1/4 X 3/8 CONNECTOR CONNECTORS DTL LIVANOVA USA INC CONNECTOR 2030100015 00803622129315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown